CLASS II ONGOING Device recall · Reported 13 Sep 2023 · FDA Enforcement Report

For intraventricular recalled by Aesculap Implant Systems

Aesculap Implant Systems is recalling For intraventricular, distributed nationwide in the US. The recall was initiated on 20 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450

Quantity recalled25 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2518-2023
FDA event ID: 92813
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jul 2023
FDA classified: 6 Sep 2023
Reported: 13 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Jul 2023	Recall initiated by company
6 Sep 2023	Classified by FDA	+48 days
13 Sep 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

Where it was distributed

US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.

Nationwide Florida Idaho Illinois Maryland North Carolina New York Oregon Rhode Island Texas

Questions about this recall

Is For intraventricular recalled?

Yes. Aesculap Implant Systems recalled For intraventricular on 20 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2518-2023.

Why was it recalled?

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

Which lots are affected?

UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450

Where was it sold?

US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aesculap Implant Systems

All 61

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26 Jul 2023Device	CLASS II	Aesculap Surgical Needle, straight, 3 1/2", width recalled	Aesculap Implant Systems	Sterility	Nationwide
17 May 2023Device	CLASS II	Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems	Aesculap Implant Systems	Other	Nationwide
3 May 2023Device	CLASS II	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled	Aesculap Implant Systems	Labeling Errors	Nationwide
7 Sep 2022Device	CLASS II	Aesculap Ennovate Set Screw Sterile-implants are used recalled	Aesculap Implant Systems	Sterility	GA, TX
17 Aug 2022Device	CLASS II	Aeos¿ Robotic Digital Microscope recalled by Aesculap Implant Systems	Aesculap Implant Systems	Device Malfunction	4 states

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